510(k) · Cleared
ClearedGen-Probe Aptima Assay for Chlamydia Trachomatis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gen-Probe, Inc. · MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Cleared on Jan 27, 2005 after an 80-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 27, 2005
- Review
- 80 days
- Class
- Class I
- Product code
- MKZ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MKZ device
- #1 K230451 Aptima® Chlamydia trachomatis Assayscore 6.4 · 1 generation · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | GEN-PROBE® APTIMA® Combo 2 Assay Named without a submission number | |
| * | — | Becton Dickenson ProbeTec ET System CT and CT/GC Assays Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MKZ devicesMKZ Dna Probe, Nucleic Acid Amplification, Chlamydia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MKZ
Too few MKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · MKZ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MKZ
1in 2025
MAUDE reports naming product code MKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The APTIMA Assay for Chlamydia trachomatis is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens*, and female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic…
Read the full statement (102 words)
The APTIMA Assay for Chlamydia trachomatis is a target amplification nucleic acid probe
test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA)
from Chlamydia trachomatis (CT) in clinician-collected endocervical, vaginal and male
urethral swab specimens, patient-collected vaginal swab specimens*, and female and male
urine specimens. The assay may be used to test specimens from symptomatic and
asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
*Patient-collected vaginal swab specimens are an option for screening women when a pelvic
exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043072 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043072: Gen-Probe Aptima Assay for Chlamydia Trachomatis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043072
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026